Nectin-4 is a cell-adhesion molecule overexpressed in urothelial carcinoma, head and neck squamous cell carcinoma (HNSCC), cervical cancer, and a subset of breast and lung tumors. Enfortumab vedotin (Padcev, Pfizer/Astellas) — an antibody-drug conjugate carrying monomethyl auristatin E (MMAE) — established Nectin-4 as a validated oncology target with FDA approvals in advanced and frontline metastatic urothelial cancer between 2019 and 2023.
The 2026 Nectin-4 landscape includes multiple next-generation conjugate programs. Bicycle Therapeutics' zelenectide pevedotin (BT8009) is a bicyclic peptide-MMAE conjugate — the same antigen as Padcev but in a small synthetic peptide format with different tissue distribution and toxicity profile. The May 21-22 ASCO 2026 abstract release delivered Phase 1 Duravelo-1 expansion at 65% ORR (13/20) and Phase 2 Duravelo-2 combination at 65% ORR (17/26) with 58% BICR-confirmed at 27-week cutoff. Corbus Pharmaceuticals' CRB-701 (SYS6002) is a next-generation Nectin-4 ADC with ASCO 2026 presentations May 29-30 in HNSCC and cervical cancer; the FDA aligned on registrational study designs enabling accelerated approval based on ORR.
Stories here cover Bicycle, Corbus, and Pfizer programs targeting Nectin-4; the urothelial-carcinoma, HNSCC, and cervical-cancer treatment landscapes; and the competitive dynamics between bicyclic peptide and antibody conjugate platforms. See #bicycle-therapeutics, #zelenectide-pevedotin, and #urothelial-cancer for adjacent threads.
Samsung Bioepis and Korean biotech IntoCell announced Wednesday July 22, 2026 that they have entered into a commercial license agreement for SBE303, one of the antibody-drug conjugate (ADC) candidates the two companies are jointly developing. SBE303 is a next-generation ADC cancer treatment targeting the Nectin-4 protein, combining Samsung Bioepis's proprietary humanized antibody with IntoCell's linker platform and a payload originally developed by IntoCell under patent license from China's Frontline. Samsung Bioepis is currently conducting a global Phase 1 clinical trial of SBE303 in the United States and Korea, with plans to evaluate safety and preliminary efficacy in 149 patients with advanced refractory solid tumors through July 2030. The deal extends Samsung Bioepis's strategic shift from a biosimilar manufacturer to a novel-drug developer, and adds to the July 2026 payload-and-conjugate consolidation wave alongside Novartis's July 6 $1.5 billion Myricx Bio acquisition (NMTi payload platform), Lonza's July 2 Nona Biosciences TfR1 blood-brain-barrier deal, SOTIO's July 14 FDA Fast Track Designation for SOT109 (CDH17 ADC), and Simris Group's July 16 appointment of former Heidelberg Pharma CEO Andreas Pahl to lead its cyanobacterial microcystin ADC payload platform.
In the June 1 rapid oral session (Abstract 4516, Yohann Loriot), the dose-optimization stage of the randomized Phase 2 Duravelo-2 trial showed the optimal dose of the bicyclic peptide-drug conjugate zelenectide pevedotin (BT8009) plus pembrolizumab produced response rates comparable to published standard-of-care data in previously untreated locally advanced or metastatic urothelial carcinoma, with roughly four-fold lower skin reactions and about half the peripheral neuropathy. The separate Duravelo-1 Phase 1 trial showed median progression-free survival comparable to standard of care in cisplatin-ineligible patients.
Corbus Pharmaceuticals reported updated CRB-701 (SYS6002) Phase 1/2 data at ASCO 2026, presented by Professor Yohann Loriot (Gustave Roussy) in the May 29 4:57 PM CDT gynecological cancer session (Abstract 5508). CRB-701 — a next-generation Nectin-4 antibody-drug conjugate with a site-specific cleavable linker, drug-antibody ratio of 2, and MMAE payload — demonstrated a confirmed objective response rate of 42.9% in second-line oropharyngeal squamous cell carcinoma (OPSCC) at 3.6 mg/kg (median duration of response 6.3 months, PFS 5.6 months) and 34.4% in second-line cervical cancer (median DOR 8.0 months, PFS 4.3 months). Both tumor types express high Nectin-4 and are HPV-driven. The FDA granted CRB-701 two Fast Track designations. Corbus is on track to start the registrational TEMPO-1 study in 2L OPSCC in summer 2026 — a randomized 250-patient trial vs investigator's-choice monotherapy with ORR as the primary endpoint for potential accelerated approval. CRB-701 competes in the Nectin-4 space with Pfizer's Padcev (enfortumab vedotin) and Bicycle Therapeutics' bicyclic-peptide zelenectide pevedotin.
The ASCO 2026 Annual Meeting opened today at McCormick Place Chicago, running through June 2, with more than 7,000 abstracts. The peptide-and-targeted-conjugate oncology cohort — pre-released in the May 21 abstract drop and the May 26 embargoed press briefing — now moves to live presentation. Friday May 29 brought the Corbus CRB-701 Nectin-4 ADC cervical/OPSCC data and the Dana-Farber/Bristol multiple myeloma and Pfizer lung cancer readouts. The peptide-mechanism slate across the meeting: Bicycle Therapeutics zelenectide pevedotin Duravelo-2 (bicyclic peptide-MMAE conjugate, oral June 1); Avacta AVA6000 FAP-Dox; BriaCell Bria-IMT cell-and-peptide immunotherapy; Sapience lucicebtide C/EBPβ antagonist (GBM); Aktis AKY-2519 B7-H3 miniprotein radioconjugate; Mayo TPIV200 folate-receptor peptide vaccine (TNBC, June 1); Telix ProstACT PSMA radioligand (June 1); plus the GLP-1 cancer slate (Abstract 3143, Roswell Park breast cancer). The targeted-conjugate categories — Nectin-4, PSMA, B7-H3, FAP, SSTR2 — are the densest peptide-adjacent oncology competition at the meeting.
Corbus Pharmaceuticals announced ASCO 2026 abstracts featuring updated clinical data from the Phase 1/2 study of CRB-701 (SYS6002), a next-generation antibody-drug conjugate targeting Nectin-4. The oral presentation in cervical cancer is scheduled for Thursday May 29 at 4:57 PM CDT; the head and neck squamous cell carcinoma (HNSCC) poster on Friday May 30 at 4:30 PM CDT. The data will include clinical response durability and HNSCC patient-subgroup analysis. Corbus reached broad alignment with the FDA on registrational-study designs in second-line HNSCC and cervical cancer, enabling potential accelerated approval based on objective response rate and full approval on overall survival. The company expects to initiate a registrational study for CRB-701 in second-line HNSCC mid-2026. CRB-701 targets the same Nectin-4 antigen as enfortumab vedotin (Padcev) and Bicycle Therapeutics' zelenectide pevedotin — the second-line HNSCC opportunity is the segment where the three programs will compete most directly.
Bicycle Therapeutics released Duravelo-2 Phase 2/3 interim analysis data at ASCO 2026 — zelenectide pevedotin (BT8009, a Nectin-4-targeting bicyclic peptide-MMAE conjugate) plus pembrolizumab in previously untreated locally advanced or metastatic urothelial cancer. The full data presentation is scheduled for Monday June 1, 8:30-8:36 AM CT in the GU Cancers oral session (Abstract 4516). The Duravelo-1 monotherapy comparator anchor — 65% ORR (13/20) in cisplatin-ineligible 1L mUC at 5 mg/m² + pembrolizumab combination, with median DOR 11.1 months in the monotherapy expansion — sets the bar for what the Duravelo-2 combination interim must clear. Bicycle's five-abstract ASCO package includes the oral Duravelo-2 piece plus four posters covering Duravelo-1 monotherapy update, BT5528 EphA2 monotherapy and combination cohorts, and BT8009 second-line urothelial data.
Bicycle Therapeutics confirmed the Duravelo-2 oral abstract presentation slot at the ASCO 2026 Annual Meeting on Monday, June 1, 8:30–8:36 a.m. CT. The abstract reports interim analysis results from Duravelo-2, a Phase 2/3 trial of zelenectide pevedotin (BT8009) plus pembrolizumab as first-line treatment for previously untreated locally advanced or metastatic urothelial carcinoma. Zelenectide pevedotin is Bicycle's Nectin-4-targeting bicyclic peptide-drug conjugate, a separate program from the EphA2-targeting nuzefatide pevedotin (BT5528) covered earlier on this site. The Q1 2026 print (April 30) reaffirmed $559.5M cash and runway to 2030 supporting the Phase 3 expansion of the platform.